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Fertility drug shortage partly due to unapproved cosmetic use

07:12 AM CDT on Wednesday, March 19, 2008

By Shern-Min Chow / 11 News

Watch the 11 News report

For couples with fertility problems, trying to get pregnant is an expensive, emotional and often extended process.

A distraught viewer contacted 11 News wondering why she could no longer find what many consider a gold standard fertility drug.

The Food and Drug Administration confirmed there’s been a nationwide shortage of the drug for over a year now, and part of that shortage comes from other folks using the drug to look better.

Raising kids and having kids can be a challenge.

For the Hocks, two years of fertility treatments finally added up to a win.

Now they are trying to grow their family with the same complicated equation of drugs and procedures — that includes the hormone HCG -- Human Chorionic Gonadotropin.  Except this time: “Our pharmacy doesn’t carry it; most of the Walgreens in the city of Houston doesn’t carry it; CVS doesn’t carry it; none of the compound pharmacies,” Kim Hock said.

Worse yet, the HCG injection must be taken within 24 hours of potential ovulation. Otherwise, another month is lost.

“It is hard,” she said. “It is hard.”

So what’s happening?  Experts blame the shortage on excess demand created by the unapproved use of HCG for weight loss.

It’s not a new idea, but HCG as a diet aid has recently been made popular by a best-selling book. The author, Kevin Trudeau, has been jailed and heavily investigated by the government for fraud and swindling and has paid millions to Uncle Sam.

A Houston doctor, who spoke off camera to 11 News, recently began prescribing HCG for weight loss. But he, not his patients, orders the drug and in larger quantities — about one shot a day for four weeks.

The FDA confirms: “Off-label use may have contributed to the shortage, but we are working with manufacturers to address the shortage.”

What do drug companies themselves say?

Dr. Byron Holt, an obstetrician-gynecologist, contacted Ferring Pharmaceuticals. It told him a key ingredient in the drug was in short supply.

“They’ve had a backlog of production,” he said.

Interestingly though, the FDA pointed out to us Ferring’s own Web site and package insert saying, “there is no substantial evidence that it increases weight loss beyond that resulting from caloric restriction, that it causes a more attractive or ‘normal’ distribution of fat.”

A Schering Plough spokeswoman said the shortage comes from “increased assisted reproductive procedures. I cannot comment on off label use .”

“I told my husband I’m just losing hope,” patient Amy Heinlein said.

Heinlein and her husband have been trying for two years. She is already on a regimen of other hormones. Last month, after trying five pharmacies and missing her chance, she called a girlfriend in tears.

“I called her crying; ‘I can’t even find it,’” she said. “It just doesn’t seem fair or right that we can’t get everything we need.”

“What it realistically means is that women who are trying to conceive ‘are out of luck right now,’” Hock said.

She finally found a dose in the medical center. HCG can be found if you look in the right places.

“The company tells me they are presently supplying the specialty pharmacies,” Dr. Holt said.

Both women are sympathetic with folks who want to lose weight.

But: “Diet and exercise: It works — I promise,” Hock said.

She’s lost 30 pounds and counting that way. What she hopes to add is a child.

There are about 20 specialty or fertility pharmacies in the United States that are reportedly being stocked with HCG. 

Drugs can be sent overnight delivery: Apothecary Shops Mail Order Pharmacy, 1 (877) 792-7684.

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